Legislation (Deferral of Sunsetting—National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations) Certificate 2020
EXPLANATORY STATEMENT
Issued by the Attorney-General in compliance with
section 15G of the Legislation Act 2003
INTRODUCTION
The Legislation (Deferral of Sunsetting—National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations) Certificate 2020 (the Certificate) is made under paragraph 51(1)(c) of the Legislation Act 2003. It is a legislative instrument for the purposes of the Legislation Act and must be registered on the Federal Register of Legislation. The Certificate is subject to the disallowance provisions of the Legislation Act as the deferred sunsetting day specified in the Certificate is after the first anniversary of the originally scheduled sunsetting day, which means that subsection 51(4) of that Act (which provides an exemption from disallowance for deferrals of 12 months or less) does not apply.
OUTLINE
Sunsetting is the automatic repeal of legislative instruments after a fixed period. The Australian Government’s sunsetting framework is established under Part 4 of Chapter 3 of the Legislation Act. The purpose of the sunsetting framework is to ensure that legislative instruments are kept up to date and only remain in force for so long as they are needed.
Subsection 50(1) of the Legislation Act provides that a legislative instrument is automatically repealed on the 1 April or 1 October immediately on or following the tenth anniversary of its registration, unless it was registered on 1 January 2005. Legislative instruments registered on 1 January 2005 are subject to the staggered sunsetting timetable set out in subsection 50(2) of the Legislation Act.
Under paragraph 51(1)(c) of the Legislation Act the Attorney-General can issue a certificate to defer the sunsetting day of an instrument for a period of either six, 12, 18 or 24 months. The instrument will then be repealed on the day specified in the certificate instead of the previously scheduled sunsetting day.
This allows instruments to continue to be in force for a further but limited period of time when they would otherwise sunset. This removes the administrative burden of remaking instruments which would have a limited duration prior to their repeal and potential replacement, or where circumstances prevent the making of replacement instruments prior to the sunsetting day.
The Certificate defers the sunsetting date of the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009 (the Regulations) from 1 April 2020 to 1 April 2022.
PROCESS BEFORE CERTIFICATE WAS MADE
Regulatory impact analysis
Certificates of deferral of sunsetting are machinery of government instruments, and are therefore not subject to the regulatory impact assessment requirements set out by the Office of Best Practice Regulation (OBPR). The OBPR reference for this standing exemption is ID19633.
Consultation before making
Before the Certificate was issued, the Attorney-General considered the general obligation to consult imposed by section 17 of the Legislation Act.
The Minister for Health, the Hon Greg Hunt MP, advised the Attorney-General of the reasons in support of issuing the Certificate. The Minister is the relevant rule-maker for the instrument for the purposes of section 6 of the Legislation Act.
The Certificate is consistent with the policy intent of the sunsetting arrangements and does not significantly alter existing arrangements. Accordingly, further consultation was unnecessary.
Statutory preconditions relevant to the Certificate
If the statutory conditions in section 51 of the Legislation Act are met, an instrument’s sunsetting day can be deferred for six, 12, 18 or 24 months by means of a certificate made under that section. In terms of process, the Legislation Act requires:
(a) the responsible rule-maker to apply to the Attorney-General in writing, and
(b) the Attorney-General to be satisfied that:
(i) the instrument would (apart from the operation of the sunsetting provisions) be likely to cease to be in force within 24 months after its sunsetting day
(ii) the proposed replacement instrument will not be able to be completed before the sunsetting day for reasons that the rule-maker could not have foreseen and avoided
(iii) the dissolution of expiration of the House of Representatives or the prorogation of the Parliament renders it inappropriate to make a replacement instrument before a new government is formed, or
(iv) the Attorney-General has approved Part 4 of Chapter 3 of the Legislation Act (Sunsetting) not applying to that instrument, and
(c) the Attorney-General to issue a certificate. The explanatory statement for the certificate must include a statement of reasons for the issue of the certificate.
The rule-maker for the Regulations, the Minister for Health, the Hon Greg Hunt MP, provided a written application to the Attorney-General seeking a deferral of sunsetting for the Regulations. On the basis of the information contained in the statement of reasons below, the Attorney-General is satisfied that the Regulations would, apart from the operation of Part 4 of Chapter 3 of the Legislation Act, be likely to cease to be in force within 24 months after their sunsetting day. As such, the criterion in subparagraph 51(1)(b)(i) of the Legislation Act is met.
Statement of Reasons for issuing the Certificate
For the purposes of subsection 51(5) of the Legislation Act this section sets out the statement of the reasons for issuing the Certificate.
The Regulations support the Commonwealth in relation to the exercise of a power by the Minister for Health under section 9B or Part VII of the National Health Act 1953. Section 9B of the National Health Act states that the Minister for Health may provide, or arrange for the provision of, designated vaccines and goods and services associated with or incidental to the provision or administration of designated vaccines. Services provided by the Commonwealth in relation to section 9B include services provided in connection with the National Immunisation Program, including the activities of the Australian Technical Advisory Group on Immunisation.
Part VII of the National Health Act concerns pharmaceutical benefits and deals with matters including the supply of and payments concerning pharmaceutical benefits and the pharmaceutical benefits scheme (PBS). Services provided by the Commonwealth in relation to Part VII include the administration of the PBS and the activities of the Pharmaceutical Benefits Advisory Committee and its sub-committees and other services carried out by the Department of Health. These services are directed at assisting the Minister for Health to exercise the relevant powers under Part VII of the National Health Act.
The Regulations set out the requirements of the associated cost recovery arrangements for these provisions. This includes prescribing the fees, defining the categories for applications, application procedures, timelines for payment, invoicing and notification, and the criteria for applicants to apply for fee exemptions and withdrawals.
PBS process improvements, as agreed in the 2017 Strategic Agreement between the Commonwealth and Medicines Australia, are proposed for implementation in two stages. Stage 1 commenced from 1 July 2019 (see the 2018-19 Mid-Year Economic Fiscal Outlook under the Improving access to medicines – streamlined listing measure), with the Regulations having gone through one significant revision as part of this. Stage 2 of the reforms are expected to be implemented from mid-2020, including further revision of the Regulations.
A 24 month deferral of the sunsetting day will allow sufficient time for industry consultation followed by the drafting of replacement Regulations which will be prepared, at the latest, for Spring 2021 parliamentary sittings. This would avoid the administrative burden of remaking the Regulations in their current form for a short period of time before they are expected to be repealed and replaced.
As such, deferral of the sunsetting date of the instruments is consistent with the policy intent of the sunsetting regime, that legislative instruments should be kept up to date and only remain in force so long as they are needed.
More information
Further details on the provisions of the Certificate are provided in Attachment A.
The Regulations which are subject to the Certificate, and which will now sunset at a later day as specified in the Certificate, are available on the Federal Register of Legislation.
Further information may be requested from the Attorney-General’s Department about the operation of the Certificate, and from the Department of Health about the Regulations.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS
The Legislation (Deferral of Sunsetting—National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations) Certificate 2020 (the Certificate) is compatible with human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 (the Human Rights Act).
Overview of the Certificate
This Certificate is made under paragraph 51(1)(c) of the Legislation Act 2003. Under that paragraph the Attorney-General can issue a certificate to defer the sunsetting day of an instrument for a period of either six, 12, 18 or 24 months. The instrument will then be repealed on the day specified in the Certificate instead of the scheduled sunsetting day. The instrument specified in this Certificate is the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009 (the Regulations).
The Regulations set out cost recovery arrangements related to the provision of designated vaccines and supply of pharmaceutical benefits under section 9B and Part VII of the National Health Act 1953 respectively. The Regulations are expected to be repealed and replaced within 24 months of their scheduled sunsetting date. Deferral of the sunsetting date would enable industry consultation followed by the drafting of replacement Regulations which will be prepared, at the latest, for the Spring 2021 parliamentary sittings.
The Certificate allows the Regulations to continue to be in force for a further but limited period of time when they would otherwise sunset. This removes the administrative burden of remaking instruments which would have a limited duration prior to their repeal and potential replacement, or where circumstances prevent the making of replacement instruments prior to the sunsetting day.
Human rights implications
The Statement of Compatibility for a certificate of deferral of sunsetting focuses on the effect of the deferral instrument, rather than the substantive effect of continuing the instruments that have been deferred.
Before issuing the Certificate, the Attorney-General was satisfied that the Regulations would, apart from the operation of the sunsetting provisions, cease to be in force within 24 months of their sunsetting date. Issuing a certificate of deferral therefore avoids the need to replace the Regulations in their current form for a short period of time before they are expected to be repealed and possibly replaced.
Instruments that are replaced will be subject to parliamentary scrutiny and oversight through the disallowance processes unless otherwise exempt. The human rights impact of the instrument will be assessed at that time, including through the requirement to prepare a further Statement of Compatibility with Human Rights.
Conclusion
This Certificate is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights Act by ensuring that any proposal to make a replacement instrument that unduly limits human rights and freedoms will be subject to parliamentary oversight and scrutiny.
ATTACHMENT A
NOTES ON THE CERTIFICATE
Section 1 Name
This section provides that the Certificate is named the Legislation (Deferral of Sunsetting—National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations) Certificate 2020. The Certificate may be cited by this name.
Section 2 Commencement
This section provides for the Certificate to commence on the day after it is registered.
Section 3 Authority
This section provides that the Certificate is made under paragraph 51(1)(c) of the Legislation Act.
Section 4 Deferral of sunsetting
This section provides that the National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2009, for which the sunsetting day is 1 April 2020, is repealed under section 51 of the Legislation Act on 1 April 2022.
Section 5 Repeal of the instrument
This section provides that the Certificate is repealed at the start of 2 April 2022.